Cardinal Health Recalls AAMI 3 Royalsilk Surgical Gowns Due to Contamination
Cardinal Health is recalling AAMI 3 Royalsilk Surgical Gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves unknown microbiological contamination in a sterile medical device, which poses a significant risk of infection and potential hospitalization, meeting the criteria for a Severe rating.
Plain-English summary
Cardinal Health is recalling approximately 7.7 million units of AAMI 3 Royalsilk Surgical Gowns (Item Code 9578NB) in size 2XL. The recall is being conducted because the gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
The affected products were distributed worldwide, including in the United States (nationwide, Puerto Rico, and Guam), the United Arab Emirates, Australia, Canada, Chile, Colombia, Costa Rica, the Dominican Republic, Israel, Mexico, Oman, Panama, the Philippines, and Saudi Arabia. The recall covers specific lot numbers manufactured in 2018 and 2019, identified by specific alphanumeric formats and facility codes.
Healthcare facilities and consumers should stop using the affected gowns and contact Cardinal Health for further instructions. The FDA has classified this as a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- AAMI 3 ROYALSILK SURGGOWN BNS 2XL, Item Code 9578NB
- Manufacturer
- Cardinal Health
- Category
- Medical Device — Surgical Gowns
- Affected units
- 7,659,634
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- 244 or greater is affected OR " " If made in 2019
- any value is affected
Distribution
Part of a larger recall action
This product is one of 39 recalled by Cardinal Health under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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